New drug may help in the fight against different types of tumors. It featured a recent clinical study. Scientists have found that tizotumab-vedotin is safe for people and provides an objective response in patients with advanced or metastatic solid tumors.
Tizotumab-vedotin - a monoclonal antibody specific for tissue factor conjugated with an agent that will destroy microtubules, monomethyl auristatin E. The antibody induces strong cytotoxicity in tumor cells with positive tissue factor in vitro and in mouse xenograft models.
In Phase I-II study (InnovaTV 201), which was attended by 174 patients with metastatic cancer or solid tumors in the late stage expressing tissue factor, scientists have studied the safety, tolerability and anti-tumor activity tizotumaba-vedotina.
In the dose-escalation phase (escalate), three of the 27 patients experienced toxicity; maximum tolerated dose (and the recommended dose for the phase II) was determined as 2.0 mg / kg.
During 2.8 months of observation in the expansion phase cohort (number of patients) 27 (18%) of the 147 participants, we need to reduce the dose. Unwanted side effects arising in the treatment, grade 3 or worse were recorded in 93 patients (63%).
The most common adverse events were bleeding from the nose (69%), neuropathy of any degree (43%) and neuropathy for at least the third degree (7%).
Three deaths were reported in the escalation phase. The connection between the used drug and the deaths has not been evaluated.
In one patient the escalation phase with metastatic cervical cancer achieved partial response with the treatment doses of 1.2 mg / kg. In the phase expansion cohort of 23 patients (15.6%) achieved confirmed objective response (partial responses were all).
The median duration of response was confirmed by 5.7 months, the median survival of responders - 3.0 months.
"Our results confirm the need for further study tizotumaba-vedotina - the researchers noted. - Currently under several studies, including InnovaTV 207 and InnovaTV 204. InnovaTV 207 (NCT03485209) - is phase II of the ongoing study, evaluating the activity, safety and tolerability of monotherapy tizotumabom-vedotinom administered every 3 weeks in patients with relapses, with locally advanced or metastatic colorectal cancer , squamous non-small cell lung cancer, pancreatic cancer, or squamous cell carcinoma of the head and neck. "
«InnovaTV 204 - it Phase II of the ongoing study, evaluating the activity, safety and tolerability of monotherapy tizotumabom-vedotinom in patients with recurrent or metastatic cervical cancer that has progressed during or after standard first-line treatment."